Effectiveness of Virtual Multicomponent Treatment for Chronic Fatigue Syndrome: VIRTUAL SFCAMINA STUDY
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 试验地点
- 3
- 主要终点
- Multidimensional Fatigue Inventory (MFI)
研究概览
简要总结
The main objective of this study is to analyse the effectiveness of the VIRTUAL SFCAMINA multicomponent treatment program as coadjuvant of treatmentas- usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL SFCAMINA treatment in the short- and long term.
详细描述
This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL SFCAMINA as coadjuvant of treatmentas- usual (TAU) vs. TAU alone.
- VIRTUAL SFCAMINA combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
- The main hypothesis is that improvement on fatigue of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia, fear avoidance and by individualized therapeutic exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Fukuda and Holmes classification criteria for Fatigue Syndrome Chronicle
- •Age equal to or greater than 18 years
- •Understand and agree to participate in the study
- •Sign the informed consent
排除标准
- •Terminal clinical conditions or scheduled treatments that may interrupt the study follow-up.
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI)
时间窗: Through study completion, an average of 3 months
Multidimensional Fatigue Inventory (MFI), a 20-item instrument consisting of several subscales including general fatigue and reduced activity. Severe fatigue it is defined as a score of greater than or equal to 13 on the MFI general fatigue subscale or greater than or equal to 10 on the MFI reduced activity subscale. The mean MFI general fatigue scores ranged from 18.3 to 18.8
次要结局
- Tampa Scale for Kinesiophobia (TSK-11)(Through study completion, an average of 3 months)
- Physical Function of the 36-Item Short Form Survey (SF-36)(Through study completion, an average of 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 3 months)